← Back to Search

Behavioral Intervention

Enhanced Care for Psychosis

N/A
Recruiting
Led By Dost Ongur, MD, PhD
Research Sponsored by Mclean Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Summary

"This trial aims to see if adding certain elements of care to the standard treatment for first-episode psychosis will increase the number of clinic visits. Participants will either receive the standard care or the standard care with

Who is the study for?
This trial is for individuals experiencing their first episode of psychosis, which could be related to conditions like schizophrenia or bipolar disorder. Participants must be receiving care at specific clinics in Massachusetts and are excluded if they don't attend these clinics.
What is being tested?
The study compares standard coordinated specialty care (CSC) with an enhanced version (CSC 2.0), which adds individual peer support, digital outreach, extra care coordination, multi-family group therapy, and cognitive remediation to see if it increases clinic visits.
What are the potential side effects?
Since the interventions involve additional support services rather than medications, traditional side effects are not a concern; however, participants may experience varying levels of comfort or emotional responses to the different types of therapies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Months Engaged in Care
Secondary study objectives
Clinic Visit Number
Clinic Visit Type
Duration of Treatment
+1 more
Other study objectives
Exploratory Analysis of symptom and functioning measures in EPINET Core Assessment Battery (CAB)
Months Engaged in Care - extension of
Proportion of Early Detachment

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Enhanced Coordinated Speciality Care (CSC 2.0)Experimental Treatment5 Interventions
CSC 2.0 arm will be offered 1:1 peer support, digital outreach, care coordination, multi-family group therapy, and cognitive remediation (if applicable).
Group II: Coordinated Specialty Care (CSC; standard of care)Active Control1 Intervention
Care as usual; no intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Care Coordination
2016
N/A
~7000
Cognitive Remediation
2010
Completed Phase 3
~1790

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalOTHER
2,993 Previous Clinical Trials
13,230,371 Total Patients Enrolled
46 Trials studying Schizophrenia
6,956 Patients Enrolled for Schizophrenia
National Institute of Mental Health (NIMH)NIH
2,869 Previous Clinical Trials
2,777,186 Total Patients Enrolled
253 Trials studying Schizophrenia
89,574 Patients Enrolled for Schizophrenia
Mclean HospitalLead Sponsor
215 Previous Clinical Trials
21,343 Total Patients Enrolled
19 Trials studying Schizophrenia
1,072 Patients Enrolled for Schizophrenia
~233 spots leftby Oct 2028
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top